NA 312.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982187543), received between Nov 27, 2018 and May 22, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, THE SURGEON TRIED USING THE PARALLEL WIRE GUIDE TO PLACE A SECOND K-WIRE AND THE MOBILE PORTION OF THE PARALLEL WIRE GUIDE WAS TOO LOOSE, MAKING IT DIFFICULT TO ACCURATELY PLACE THE SECOND WIRE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO PATIENT CONSEQUENCE. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072559 ↗
• MalfunctionDec 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDE WAS NOT STAYING PARALLEL FOR PRODUCT 312.01. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.8MM ADJUSTABLE PARALLEL WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915807 ↗
• MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 WHILE ATTEMPTING TO TIGHTEN THE TROCAR WITH THE ADJUSTABLE PARALLEL WIRE GUIDE, THE TROCAR WOULD NOT TIGHTEN OR THREAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN TROCAR (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 2.8MM ADJUSTABLE PARALLEL WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10397304 ↗
• MalfunctionApr 8, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON JANUARY 14, 2020, THE 2.8 MM ADJUSTABLE PARALLEL WIRE GUIDE HAD A STUCK THREADED NUT NOT ALLOWING THE MOVABLE SLEEVE TO LOCK INTO PLACE DURING PROXIMAL FEMUR USING 7.3MM CANNULATED SCREW SET. ACTION TAKEN THE SURGEON ATTEMPTED TO FREE THE STUCK NUT WITH PLIERS BUT WAS UNSUCCESSFUL AND PROCEEDED WITH THE SURGERY BY USING A FREEHAND TECHNIQUE FOR INSERTING THE WIRE. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME AS PLANNED. CONCOMITANT DEVICES REPORTED: UNKNOWN GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 9936419 ↗
• MalfunctionJun 26, 2019Device Difficult to Maintain; Device Difficult to Maintain

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS:IT WAS REPORTED THAT ON (B)(6) 2019, AN ADJUSTABLE WIRE GUIDE WAS INDICATED AS BECOME BENT AND WAS NOT FUNCTIONING PROPERLY BY THE MEDICAL DEVICE REPROCESSING (MDR) STAFF. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8737439 ↗
• MalfunctionMar 12, 2019Component Missing; Component Missing

  IT WAS REPORTED ON AN UNKNOWN DATE, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT AN ADJUSTABLE PARALLEL GUIDE WIRE HAD A MISSING SECONDARY GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8414949 ↗
• MalfunctionNov 27, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON THE FIFTH DAY OF UNKNOWN MONTH, 2018. DURING THE PROCEDURE, AN ADJUSTABLE PARALLEL WIRE GUIDE WAS BENT. ANOTHER WIRE GUIDE FROM THE SET WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR ONE (1) ADJUSTABLE PARALLEL WIRE GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8106847 ↗